Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced the publication in Menopause: The
Journal of The North American Menopause Society of data from a
Phase 1/2 clinical trial that evaluated the safety and
pharmacokinetics of DARE-HRT1. DARE-HRT1, an investigational
intravaginal ring (IVR) designed to release bio-identical
17β2-estradiol (E2) and bio-identical progesterone (P4)
continuously over a 28-day period as part of a hormone therapy
regimen, is part of Daré’s proprietary IVR technology platform
originally developed by Dr. Robert Langer from the Massachusetts
Institute of Technology and Dr. William Crowley from Massachusetts
General Hospital and Harvard Medical School.
The article, titled “A phase 1/2, open-label,
parallel group study to evaluate the safety and pharmacokinetics of
DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8
mg progesterone intravaginal rings) over 12 weeks in healthy
postmenopausal women,” is available online through both the Latest
Articles section of the Menopause journal’s website, as well as the
Scientific & Clinical Publications section of Daré’s
website, and will be published in Volume 30, Issue 8 of
Menopause.
The study enrolled a total of 21 subjects, who
were randomized (1:1) to receive one of two versions of DARE-HRT1,
either IVR1 (E2 80 μg/d with P4 4 mg/d) or IVR2 (E2
160 μg/d with P4 8 mg/d), and used DARE-HRT1 over 12
weeks (three 28-day cycles). The study results demonstrated both
versions of DARE-HRT1 were safe and released E2 in systemic
concentrations in the low, normal premenopausal range and P4 in
systemic concentrations predictive of endometrial protection. Data
from the study support continued clinical development of DARE-HRT1
for the treatment of menopausal symptoms.
Daré previously reported positive topline data
from the Phase 1/2 study of DARE-HRT1 in January 2023 and October
2022.
DARE-HRT1 has the potential to be the first
FDA-approved product to offer vaginal delivery of combination
bio-identical estradiol and bio-identical progesterone therapy in a
convenient monthly format. Daré plans to advance DARE-HRT1 into a
single Phase 3 clinical trial to support a new drug application for
DARE-HRT1 for the treatment of moderate to severe VMS due to
menopause in women with intact uteri.
“The clinical and quality of life issues
associated with menopause continue to take center stage as women
and healthcare providers increasingly appreciate the need for more
treatment options. We are excited to have the results of our Phase
1/2 study published in this prestigious peer-reviewed journal and
we believe the study results underscore DARE-HRT1’s compelling
therapeutic value proposition and its potential to be a
first-in-category non-oral and convenient non-daily option for
women suffering from vasomotor symptoms associated with menopause,
such as hot flashes and night sweats,” said Sabrina Martucci
Johnson, President and CEO of Daré Bioscience. “Guidance from the
North American Menopause Socierty asserts that hormone therapy
remains the most effective treatment for vasomotor symptoms.
Non-oral hormone therapy, including transdermal and vaginal routes
of administration, may offer potential advantages compared with
oral hormone therapy because non-oral routes bypass the first-pass
hepatic effect. We look forward to continuing our preparation for
the planned Phase 3 study and to providing updates on our
progress.”
DARE-HRT1 505(b)(2) Regulatory Pathway
Following clinical development, Daré intends to
leverage the existing safety and efficacy data on the active
ingredients in DARE-HRT1, estradiol and progesterone, to utilize
the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to
obtain marketing approval of DARE-HRT1 in the U.S.
Daré intends to seek FDA approval of DARE-HRT1
for the treatment of moderate to severe VMS due to menopause in
women with intact uteri. Based on pre-IND communications with the
FDA and the topline PK data from the DARE-HRT1 Phase 1 / 2 study,
Daré believes FDA approval of DARE-HRT1 for that indication is
achievable via the 505(b)(2) pathway supported by a single,
placebo-controlled, Phase 3 clinical trial of DARE-HRT1 and a
scientifically justified PK “bridge” (via a relative
bioavailability trial) between DARE-HRT1 and the selected listed
estradiol and progesterone drugs. Ongoing activities to support
progressing directly into a single Phase 3 study to support
registration include manufacturing and non-clinical studies to
support the IND submission and the planned IND-opening Phase 3
study.
About Menopause
Menopause is defined as the final menstrual
period and is typically confirmed after a woman has missed her
period for 12 consecutive months. Most women experience menopause
between ages 40 and 58.1 An estimated 45 million women in
the U.S. are approaching or in menopause, which results
in a decrease in estrogen and other hormones.1,2 Hot flashes,
vaginal dryness and loss of bone density are frequently associated
with menopause. Night sweats (hot flashes that occur during sleep)
often cause sleep disturbance, and vaginal atrophy (the drying
and thinning of vaginal tissues) can cause a feeling of vaginal
tightness during sex along with pain, burning, or
soreness.1 Hence, management of menopausal symptoms can impact
quality of life, productivity and health. The North American
Menopause Society (NAMS) believes that hormone therapy is the
most effective treatment for VMS and the genitourinary syndrome of
menopause and observes that a non-oral route may offer potential
advantages over oral routes of administration because non-oral
routes bypass the first-pass hepatic effect.2
- Menopause 101: A primer for the
perimenopausal. NAMS, accessed 17 June
2023. http://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/menopause-101-a-primer-for-the-perimenopausal.
- NAMS Position Statement. The
2022 hormone therapy position statement of The North American
Menopause Society. Menopause: The Journal of The North American
Menopause Society Vol. 29, No. 7, pp. 767-794 DOI:
10.1097/GME.0000000000002028.
https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company
committed to advancing innovative products for women’s health. The
company’s mission is to identify, develop and bring to market a
diverse portfolio of differentiated therapies that prioritize
women's health and well-being, expand treatment options, and
improve outcomes, primarily in the areas of contraception, vaginal
health, reproductive health, menopause, sexual health and
fertility.
Daré’s first FDA-approved product, XACIATO™
(clindamycin phosphate) vaginal gel, 2% is a lincosamide
antibacterial indicated for the treatment of bacterial vaginosis in
female patients 12 years of age and older, which is under a global
license agreement with Organon. XACIATO is a clear, colorless,
viscous gel, to be administered once intravaginally as a single
dose. Daré’s portfolio also includes potential first-in-category
candidates in clinical development: Ovaprene®, a novel,
hormone-free monthly intravaginal contraceptive whose U.S.
commercial rights are under a license agreement with Bayer;
Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to
treat female sexual arousal disorder utilizing the active
ingredient in Viagra®; and DARE-HRT1, a combination bio-identical
estradiol and progesterone intravaginal ring for menopausal hormone
therapy. To learn more about XACIATO, Daré’s full portfolio of
women’s health product candidates, and Daré’s mission to deliver
differentiated therapies for women, please visit
www.darebioscience.com.
Daré may announce material information about its
finances, product and product candidates, clinical trials and other
matters using the Investors section of its website
(http://ir.darebioscience.com), SEC filings, press releases, public
conference calls and webcasts. Daré will use these channels to
distribute material information about the company, and may also use
social media to communicate important information about the
company, its finances, product and product candidates, clinical
trials and other matters. The information Daré posts on its
investor relations website or through social media channels may be
deemed to be material information. Daré encourages investors, the
media, and others interested in the company to review the
information Daré posts in the Investors section of its website and
to follow these Twitter accounts: @SabrinaDareCEO and
@DareBioscience. Any updates to the list of social media channels
the company may use to communicate information will be posted in
the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements. Forward-looking
statements, in some cases, can be identified by terms such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“design,” “intend,” “expect,” “could,” “plan,” “potential,”
“predict,” “seek,” “should,” “would,” “contemplate,” “project,”
“target,” “objective,” or the negative version of these words and
similar expressions. In this press release, forward-looking
statements include, but are not limited to, statements relating to
DARE-HRT1’s potential as a safe and effective hormone therapy for
symptoms of menopause, DARE-HRT1’s potential to be the first
FDA-approved monthly IVR product delivering both estrogen and
progestogen hormone therapy for symptoms of menopause, the
importance of the results of the Phase 1 / 2 clinical study to Daré
and DARE-HRT1, the anticipated regulatory approval pathway for
DARE-HRT1, and the potential for FDA approval of DARE-HRT1 for the
treatment of moderate to severe VMS due to menopause in women with
intact uteri based on a single Phase 3 clinical trial together with
study data that establishes a scientific bridge to the selected
listed drugs. Forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause Daré’s actual
results, performance or achievements to be materially different
from those expressed or implied by the forward-looking statements
in this press release, including, without limitation: the risk that
positive findings in early clinical and/or nonclinical studies of a
product candidate may not be predictive of success in subsequent
clinical and/or nonclinical studies of that candidate; Daré’s
ability to develop, obtain FDA or foreign regulatory approval for,
and commercialize its product candidates and to do so on
communicated timelines; failure or delay in starting, conducting
and completing clinical trials of a product candidate; Daré’s
ability to design and conduct successful clinical trials, to enroll
a sufficient number of patients, to meet established clinical
endpoints, to avoid undesirable side effects and other safety
concerns, and to demonstrate sufficient safety and efficacy of its
product candidates; Daré’s dependence on third parties to conduct
clinical trials and manufacture and supply clinical trial material
and commercial product; the risk that development of a product
candidate requires more clinical or nonclinical studies than Daré
anticipates, or that the duration of a study or number of study
subjects must be significantly greater than anticipated; Daré’s
ability to raise additional capital when and as needed to advance
its product candidates, execute its business strategy and continue
as a going concern; the loss of, or inability to attract, key
personnel; the effects of the COVID-19 pandemic, macroeconomic
conditions such as inflation, rising interest rates and
geopolitical events on Daré’s operations, financial results and
condition, and ability to achieve current plans and objectives,
including the potential impact of the pandemic on Daré’s ability to
timely commence, enroll, conduct and report results of its clinical
trials and on the ability of third parties on which Daré relies to
assist in the conduct of its business to fulfill their contractual
obligations to Daré; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; the risk that developments by competitors make
Daré’s product or product candidates less competitive or obsolete;
difficulties establishing and sustaining relationships with
development and/or commercial collaborators; failure of Daré’s
product or product candidates, if approved, to gain market
acceptance or obtain adequate coverage or reimbursement from
third-party payers; Daré’s ability to retain its licensed rights to
develop and commercialize a product or product candidate; Daré’s
ability to satisfy the monetary obligations and other requirements
in connection with its exclusive, in-license agreements covering
the critical patents and related intellectual property related to
its product and product candidates; Daré’s ability to adequately
protect or enforce its, or its licensor’s, intellectual property
rights; the lack of patent protection for the active ingredients in
certain of Daré’s product candidates which could expose its
products to competition from other formulations using the same
active ingredients; product liability claims; governmental
investigations or actions relating to Daré’s product or product
candidates or the business activities of Daré, its commercial
collaborators or other third parties on which Daré relies; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; cyber attacks, security
breaches or similar events that compromise Daré’s technology
systems or those of third parties on which it relies and/or
significantly disrupt Daré’s business; and disputes or other
developments concerning Daré’s intellectual property rights. Daré’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. For a
detailed description of Daré’s risks and uncertainties, you are
encouraged to review its documents filed with the SEC including
Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Daré undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
Contacts:
Investors on behalf of Daré Bioscience,
Inc.:Lee RothBurns McClellanlroth@burnsmc.com
646.930.4406
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonEvoke Canalejake.robison@evokegroup.com 619.849.5383
Source: Daré Bioscience, Inc.
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